Revascularisation of Chronic Limb Threatening Ischaemia in Patients with no Pedal Arteries Leads to Lower Midterm Limb Salvage.

OBJECTIVE: Chronic limb threatening ischaemia (CLTI) involving the infragenicular arteries is treated by distal angioplasty or pedal bypass; however, this is not always possible, due to chronically occluded pedal arteries (no patent pedal artery, N-PPA). This pattern represents a hurdle to successful revascularisation, which must be limited to the proximal arteries. The aim of the study was to analyse the outcome of patients with CLTI and N-PPA after a proximal revascularisation. METHODS: All patients with CLTI submitted to revascularisation in a single centre (2019 - 2020) were analysed. All angiograms were reviewed to identify N-PPA, defined as total obstruction of all pedal arteries. Revascularisation was performed with proximal surgical, endovascular, and hybrid procedures. Early and midterm survival, wound healing, limb salvage, and patency rates were compared between N-PPA and patients with one or more patent pedal artery (PPA). RESULTS: Two hundred and eighteen procedures were performed. One hundred and forty of 218 (64.2%) patients were male, mean age 73.2 ± 10.6 years. The procedure was surgical in 64/218 (29.4%) cases, endovascular in 138/218 (63.3%), and hybrid in 16/218 (7.3%). N-PPA was present in 60/218 (27.5%) cases. Eleven of 60 (18.3%) cases were treated surgically, 43/60 (71.7%) by endovascular and 6/60 (10%) by hybrid procedures. Technical success was similar in the two groups (N-PPA 85% vs. PPA 82.3%, p = .42). At a mean follow up of 24.5 ± 10.2 months, survival (N-PPA 93.7 ± 3.5% vs. PPA 95.3 ± 2.1%, p = .22) and primary patency (N-PPA 53.1 ± 8.1% vs. PPA 55.2 ± 5%, p = .56) were similar. Limb salvage was significantly lower in N-PPA patients (N-PPA 71.4 ± 6.6% vs. PPA 81.5 ± 3.4%, p = .042); N-PPA was an independent predictor of major amputation (hazard ratio [HR] 2.02, 1.07 - 3.82, p = .038) together with age > 73 years (HR 2.32, 1.17 - 4.57, p = .012) and haemodialysis (2.84, 1.48 - 5.43, p = .002). CONCLUSION: N-PPA is not uncommon in patients with CLTI. This condition does not hamper technical success, primary patency, and midterm survival; however, midterm limb salvage is significantly lower than in patients with PPA. This should be considered in the decision making process.

Proximal Aortic Coverage and Clinical Results of the Endovascular Repair of Juxta-/Para-renal and Type IV Thoracoabdominal Aneurysm with Custom-made Fenestrated Endografts.

BACKGROUND: Juxta-renal (JAAA)/para-renal (PAAA) and type IV-thoracoabdominal (TAAA) aneurysms can be repaired by custom-made fenestrated endografts (CM-FEVAR). Differently from open repair, a relatively long segment of healthy proximal aorta needs to be covered to achieve a durable sealing, and this may be considered a disadvantage of the endovascular approach. We aimed to quantify the additional proximal aortic coverage in JAAAs, PAAAs, and type-IV TAAAs treated with CM-FEVAR and to evaluate its impact on early/follow-up clinical outcomes. METHODS: Between 2006 and 2018, preoperative, intraoperative, and postoperative data of JAAAs, PAAAs, and type-IV TAAAs submitted to CM-FEVAR were collected. The length of proximal healthy aortic coverage was evaluated on the preoperative endograft planning as the distance between the top of the CM-FEVAR endograft and the hypothetical level of aortic cross-clamping in case of open repair (type-IV TAAA-above the celiac trunk; PAAA-above the superior mesenteric artery; JAAA-above the lowest renal artery). Spinal cord ischemia (SCI), bowel ischemia (BI), renal function worsening (RFW) (estimated glomerular filtration rate reduction > 25% of the baseline level - RFW), and mortality were assessed at 30-day. Survival, target visceral vessel (TVV) patency, and freedom from reinterventions (FFRs) were assessed during follow-up by Kaplan-Meier analysis R2. RESULTS: One hundred forty-seven cases were submitted to CM-FEVAR, for 72 (49%) JAAAs, 46 (31%) PAAAs, and 29 (20%) type IV-TAAAs, with 1(4-3%), 2 (28-19%), 3 (48-33%), and 4 (67-45%) fenestrations. JAAAs required a fenestration + bridging stent graft for the superior mesenteric artery and celiac trunk, in 46(64%) and 24(33%) cases, respectively. Nineteen (41%) PAAAs required a fenestration + bridging stent graft for the celiac trunk. The mean proximal additional aortic coverage was 48 ± 2 mm with no differences among JAAAs (52 ± 1 mm), PAAAs (42 ± 2 mm), and type IV-TAAAs (50 ± 2 mm) (P.09). Technical success, defined as correct endograft deployment, with TVV patency, absence of type I-III endoleaks, iliac leg stenosis/occlusions, open surgical conversion, and 24-hour mortality, was achieved in 98% of cases. Failures occurred for 1 type-III endoleak (type-IV TAAA) and 2 renal artery losses (PAAA and type IV-TAAA). The only case of SCI (0.7%) occurred in a type-IV TAAA where the proximal healthy aortic coverage was 80 mm. One BI was caused by acute thrombosis of the bridging stent graft for the superior mesenteric artery at 24 hours in 1 type IV-TAAA (0.7%). Thirty-five patients (24%) suffered postoperative RFW and required hemodialysis in 1 (0.7%) JAAA with severe preoperative chronic renal failure. There was no difference of proximal additional aortic coverage between patients with (49 ± 29 mm) and without (48 ± 23 mm) RFW (P.2). The 30-day mortality was 1.4%. The mean follow-up was 37 ± 2 months with no cases of aneurysm-related late mortality. Survival was 94%, 89%, and 75% at 1, 2, and 5 years, respectively. TVV patency was 97%, 97%, and 93% at 1, 2, and 5 years, respectively. FFR was 98%, 95%, and 87% at 1, 2, and 5 years, respectively. CONCLUSIONS: Custom-made FEVAR requires a mean proximal additional aortic coverage of 48 ± 2 mm above the level of hypothetical aortic cross-clamping in case of open repair. This aspect should be considered for CM-FEVAR indication in JAAAs, PAAAs, and type-IV TAAAs; nevertheless, it does not appear to be associated with negative early and follow-up clinical sequelae.

Kissing Stent Technique for TASC C-D Lesions of Common Iliac Arteries: Clinical and Anatomical Predictors of Outcome.

BACKGROUND: The endovascular treatment of peripheral artery obstructive disease in Trans-Atlantic Inter-Society (TASC) C and D lesions involving the aortic bifurcation is a matter of debate. The aim of this study is to evaluate the technical and clinical success of kissing stenting in this context and to analyze predictors of outcome. METHODS: All patients treated for aortoiliac TASC C and D lesions with kissing stenting (from 2012 to 2017) in a 6-year period were retrospectively analyzed. Preoperative anatomical features were evaluated by reviewing computed tomography angiography images to identify severe iliac calcifications (SICs) versus not SIC (NSICs). Primary end points were as follows: technical success (TS), procedural success, primary patency (PP), and clinical success (CS). Secondary end points were as follows: secondary patency, assisted patency, survival, mid-term procedure-related complications, and risk factors that affected TS and mid-term results. RESULTS: In a 6-year period, 51 patients fulfilled the inclusion criteria. TS was achieved in 49 (96.1%) cases. Thirty-one patients (60.8%) received a dual antiplatelet therapy (DAPT) for at least 1 month after the procedure. 30-day CS was 94.1%. Median follow-up was 45.7 months (IQR: 24.5, 8-86 range). The CS was 92.6% at 3 years, with a PP of 86.8% and a secondary patency of 93.2% at 3 years. Six (13.2%) iliac axis occluded during the first follow-up year. NSIC was statistically and independently associated with a lower PP (73% vs. 96%, P = 0.03); DAPT was statistically and independently associated with higher PP than single antiplatelet therapy (96% vs. 75%, P = 0.03); these results were confirmed by Cox regression analysis (HR: 0.14, 95%, IC: 0.01-0.89, P = 0.05 for DAPT analysis; HR: 6.8, 95%, IC: 1.21-59, P = 0.05 for NSIC analysis). CONCLUSIONS: Endovascular treatment for TASC C-D is an effective technique. Postoperative stent occlusion is higher in patients with no DAPT and it usually occurs during the first postoperative year. Preoperative NSIC lesions are associated with reduced PP at 3 years of follow-up.

The benefit of combined carbon dioxide automated angiography and fusion imaging in preserving perioperative renal function in fenestrated endografting.

BACKGROUND: Contrast-induced nephropathy is a possible adverse event in fenestrated endovascular aneurysm repair (FEVAR). Automated carbon dioxide (CO2) angiography has been proposed as an alternative to iodinated contrast medium (ICM) for standard endovascular aneurysm repair; however, its use in FEVAR has not yet been investigated. The aim of this study was to analyze the possibility of reducing the amount of procedural ICM during FEVAR by combining CO2 with intraprocedural three-dimensional preoperative computed tomography angiography images overlaid on two-dimensional live fluoroscopy images (fusion imaging [FI]). METHODS: Between January and April 2018, juxtarenal and pararenal abdominal aortic aneurysms and type IV thoracoabdominal aortic aneurysms undergoing FEVAR with a CO2 + FI protocol were prospectively collected and compared with FEVAR cases treated with standard procedural imaging (ICM + FI) between June and December 2017. Preoperative, intraoperative, and postoperative data were analyzed. Amount of ICM, procedure and fluoroscopy time, total radiation dose (dose-area product), endoleaks, and technical success (defined as absence of type I or type III endoleak and target visceral vessel patency at completion angiography) were assessed. The 30-day renal function worsening (estimated glomerular filtration rate reduction >25% of the preoperative value) and 6-month reinterventions were also considered. Analysis was done by Fisher exact and Mann-Whitney tests. RESULTS: Forty-five patients were enrolled, 15 (33%) managed by CO2 + FI and 30 (67%) by ICM + FI. The two groups were homogeneous in their clinical, anatomic, and endograft features. Median ICM administration was significantly lower in CO2 + FI compared with ICM + FI (41 mL [interquartile range (IQR), 26 mL] vs 138.5 mL [IQR, 88 mL]; P = .001). There was no difference in median procedure time, fluoroscopy time, and dose-area product between CO2 + FI and ICM + FI. Intraoperative type I or type III endoleak detection was similar (P = 1) in CO2 + FI (7%) and ICM + FI (7%), with immediate repair and technical success achieved in all cases. Early type II endoleak did not differ in the two groups (CO2 + FI, 27%; ICM + FI, 20%; P = .7). Postoperative renal function deteriorated in two patients (13%) in the CO2 + FI group vs eight patients (27%) in the ICM + FI group (P = .04). The median increase of postoperative creatinine concentration was smaller in the CO2 + FI group than in the ICM + FI group (0.09 mg/dL [IQR, 0.03 mg/dL] vs 0.3 mg/dL [IQR, 0.4 mg/dL]; P = .04). The median hospitalization time was shorter in the CO2 + FI group (5 days [IQR, 1 day] vs 8 days [IQR, 4 days]; P = .002). No reintervention was necessary at 30-day and 6-month follow-up in either group. CONCLUSIONS: CO2 + FI is safe and effective in FEVAR and allows the amount of ICM to be significantly reduced, leading to shorter hospitalization time and better renal function preservation at 30 days. Technical success, procedure and fluoroscopy time, radiation dose, and 6-month reinterventions are comparable with those of the standard ICM imaging protocol for FEVAR. Based on this preliminary experience, CO2 + FI may be proposed as an effective tool to reduce the overall amount of procedural ICM, with consequent benefits on perioperative renal function.

The Efficacy of a Protocol of Iliac Artery and Limb Treatment During EVAR in Minimising Early and Late Iliac Occlusion.

OBJECTIVE: Iliac limb occlusion (ILO) is a complication of endovascular aortic repair (EVAR) and requires re-intervention in most cases. Attention to any intra-operative defect of iliac limbs and arteries may prevent ILO. The study aimed to analyse the long term effect of an intra-operative protocol of iliac limb treatment during EVAR on ILO. METHODS: Patients treated from 2012 to 2017 for abdominal aortic aneurysm (AAA) with standard EVAR were collected prospectively. Pre-operative computed tomography angiography anatomical characteristics were evaluated. The protocol for intra-operative iliac limb management was: a. pre-EVAR angioplasty of common/external iliac artery stenosis; b. precise contralateral iliac limb deployment at the same level of the flow divider; c. iliac limb kissing ballooning with high pressure non-compliant balloons; d. iliac limb stenting for residual tortuosity/kink and adjunctive external iliac stenting for residual stenosis/dissection after EVAR. ILO was evaluated at 30 days and at follow up, which was performed by duplex ultrasonography before discharge, at three, six, and 12 months and yearly thereafter. Kaplan-Meier and Cox linear regression were used. RESULTS: Four hundred and forty-two patients and 884 iliac limbs were included in the study. Severe iliac tortuosity and calcification were present in 15% (132/884) and 8% (70/884), respectively. External iliac angioplasty and stenting of iliac limb were performed in 2% (18/884) and 9.5% (84/884) of limbs. The thirty day mortality was 1.6%, with no ILO. At a mean follow up of 33 ± 12 months, ILO occurred in 7/884 (0.8%) limbs of six patients. Five ILO were treated by endovascular relining, two surgically: one by femorofemoral bypass and one by surgical explant. On univariable analysis, sac shrinkage was significantly associated with ILO (HR 1, 95% CI 0.8-2.5, p = .043). CONCLUSION: A protocol of aggressive iliac limb treatment in EVAR leads to a very low rate of late ILO. The role of sac shrinkage in ILO should be investigated further.

Early and Mid-term Efficacy of Fenestrated Endograft in the Treatment of Juxta-Renal Aortic Aneurysms.

BACKGROUND: The aim of this study was to report early and mid-term outcomes of fenestrated endografting (FEVAR) for juxtarenal aneurysm (J-AAAs). METHODS: Between 2008 and 2017, all consecutive J-AAAs treated by FEVAR were prospectively collected. Early endpoints were technical success, renal function worsening, and 30-day mortality. Follow-up endpoints were survival, freedom from reinterventions (FFRs), target visceral vessels (TVVs) patency, J-AAAs shrinkage, and renal function worsening. RESULTS: Among 181 cases who underwent FB-EVAR, 66 (36%) were J-AAAs. Endograft with 1, 2, 3, and 4 fenestrations were planned in 2 (3%), 22 (33%), 27 (41%) and 15 (23%) cases, respectively. Overall, 236 TVVs were treated by fenestrations and scallops. Technical success was achieved in 65 (99%) cases. The only failure occurred for a type III endoleak requiring renal artery relining. No TVVs were lost. Renal function worsening occurred in 7 (10%) cases: 4 returned to baseline within 30-day, 1 required hemodialysis and died within 30 days (1.5%). This was the only case of 30-day mortality. The mean follow-up was 46 ± 32 months. Aneurysm sac shrinkage or stability was observed in 42 (64%) and 22 (33%) cases, respectively. Two patients (3%) with persistent type II endoleak had sac enlargement and required reinterventions. Freedom from reinterventions at 5 years was 88%. An asymptomatic celiac trunk occlusion (accommodated by a scallop) occurred at 24 months in a case with a severe preoperative stenosis. No late renal arteries occlusions or type I-III endoleaks occurred. Overall, renal function worsening was reported in 5 (8%) patients during follow-up. Survival at 5 years was 67%, with no j-AAA-related mortality. COPD was the only independent predictor for mortality at the multivariate analysis (P: 0.021; OR: 5.3; 95% CI, 1.3-21.9). CONCLUSIONS: FEVAR for J-AAAs is safe and effective at early and mid-term follow-up. According to these results, it could be proposed as the first-line treatment in high-risk patients if anatomically fit. Long-term survival is reduced in the presence of preoperative COPD.

Multistep and Multidisciplinary Management for Post-irradiated Carotid Blowout Syndrome in a Young Patient With Oropharyngeal Carcinoma: A Case Report.

BACKGROUND: Carotid blowout syndrome is a severe complication of head and neck cancer, associated with high mortality and morbidity. METHODS: We present a case of acute hemorrhage from the carotid artery of a 59-year-old man with a history of chemoradiotherapy for lingual base and oropharyngeal squamous cell carcinoma. The case was managed by a staged multidisciplinary approach of open arterial reconstruction, after initial endovascular hemorrhage control using stent graft. RESULTS: The patient was discharged to home with patent carotid artery, no sign of infection or bleeding, and autonomous ambulation. A CT/PET scan performed 6 months later confirmed healing and absence of tumor recurrence. CONCLUSIONS: A multidisciplinary approach involving vascular surgeons, ENT surgeons, plastic and maxillofacial surgeons is particularly appropriate in the management of carotid blowout syndrome to warrant a durable and effective repair of all the anatomical structures involved.

A prognostic score for clinical success after revascularization of critical limb ischemia in hemodialysis patients.

OBJECTIVE: The revascularization of critical limb ischemia (CLI) in hemodialysis (HD) patients features poor results in terms of patient survival and limb salvage. Recent predictive models in CLI revascularization did not specifically address HD patients. The aim of this study was to define risk factors for clinical success (CS) after revascularization of CLI in HD patients and to transform findings in a prognostic score. METHODS: A retrospective study was conducted of prospectively gathered data, including consecutive HD patients treated for CLI from January 2004 to December 2012. Patients' demographics, comorbidities, CLI stage (Rutherford classification), tissue loss (Texas University Wound classification [TUWC]), and type of revascularization were assessed. End points were CS after revascularization (amputation-free and reintervention-free survival) and a prognostic score for CS based on significant risk factors (multivariable analysis). RESULTS: In the study period, 131 patients (mean age, 70.2 ± 9.9 years; male, 76.3%) with a total of 180 limbs were treated. Endovascular (52.8%), surgical (28.9%), or hybrid (10.6%) revascularization was performed in 163 (90.6%) limbs in 117 patients. The mean (± standard deviation) follow-up was 20.8 ± 21.1 months. Considering revascularized patients, CS was 47.9%, 30.8%, and 17.8% at 6, 12, and 24 months, respectively. On multivariable analysis, age (hazard ratio [HR], 1.03; 95% confidence interval [CI], 1.01-1.05; P = .005), coronary artery disease (CAD; HR, 1.55; 95% CI, 1.04-2.32; P = .032), and TUWC stage D (HR, 1.80; 95% CI, 1.22-2.67; P = .003) were independent negative factors. Type of revascularization had no influence on CS. The score for predicting CS was 0.026 × age (years) + 0.441 × CAD + 0.59 × TUWC stage D. CAD and TUWC stage D were 1 in the presence of disease and 0 in the absence of disease. The score has a significant discrimination power of 75.5% (P = .036), with a best cutoff value of 2.07. Patients with a CS score <2.07 would have a low risk of clinical failure, whereas patients with a CS score >2.07 would have a high risk. There were 31 (26.5%) cases of low-risk score and 86 (73.5%) cases of high-risk score. Cases with low-risk score had a CS at 1 year of 51.6% compared with 23.3% in cases with high-risk score. CONCLUSIONS: CS after revascularization in HD patients remains poor independent of the type of revascularization. A prognostic model based on age, history of CAD, and severity of CLI (TUWC stage D lesion) can estimate an individual's chances of CS and may help in the decision-making process.

Anatomical Predictors of Flared Limb Complications in Endovascular Aneurysm Repair.

Purpose: To evaluate possible predictors of complications with flared iliac stent-graft limbs for ectatic common iliac arteries (CIAs) associated with abdominal aortic aneurysms treated with endovascular aneurysm repair (EVAR). Materials and Methods: A retrospective comparative analysis was conducted of 533 EVAR patients (mean age 75 years; 442 men) treated between 2012 and 2017 who had complications associated with the stent-graft limbs (n=1066). Complications, including type Ib endoleak, type IIIa endoleak, and limb occlusion, were compared between patients with nondilated (<16 mm) CIAs treated with standard iliac limbs (SLs, n=808) vs patients with ectatic CIAs treated with flared limbs (FLs, n=258). Follow-up included a duplex scan at 3, 6, and 12 months and yearly thereafter; computed tomography angiography was performed in case of iliac complications. Risk factors for iliac complications in FLs were investigated using Cox regression and Kaplan-Meier analyses; results of the regression analysis are presented as the hazard ratio (HR) and 95% confidence interval (CI). Results: Overall, no iliac complications occurred at 30 days, but over a mean follow-up of 38±8 months, there were 10 (1%) events (4 limb occlusions, 6 type Ib endoleaks): 7 (3%) in FLs and 3 (0.4%) in SLs (p=0.20). Kaplan-Meier analysis found no differences at 5 years in SLs vs FLs for freedom from limb occlusion (99%±1% vs 98%±1%, respectively; p=0.30) or type Ib endoleak (96%±3% vs 97%±1%, respectively; p=0.44). Similarly, the overall 5-year iliac complication rates were similar in SLs vs FLs (96%±3% vs 95%±2%, p=0.21). Regression analysis found CIA length ≤30 mm (HR 4.7, 95% CI 1.02 to 21.6, p=0.04) and a diameter ≥20 mm (HR 7.8, 95% CI 1.05 to 64.8, p=0.03) to be independent predictors of iliac complications in FLs. Kaplan-Meier estimates of iliac complication-free survival in FLs were significantly worse when the CIA length was ≤30 mm (79%±9% vs 98%±1%, p=0.003) or the diameter was ≥20 mm (85%±7% vs 99%±1%, p=0.02). The combination of both risk factors produced significantly poorer iliac complication-free survival compared with cases in which there was one or no risk factor (67%±19% vs 96%±2% vs 99%±1%, respectively; p<0.001). Conclusion: Iliac limb complications are infrequent in EVAR, regardless of the type of iliac limb chosen; however, CIAs ≤30 mm in length or ≥20 mm in diameter significantly increased the risk of late iliac complications in FLs. If both characteristics were present, this risk was further elevated.

Planning and Endograft Related Variables Predisposing to Late Distal Type I Endoleaks.

OBJECTIVE: Late distal type I endoleak (ELIB) hampers the outcome of endovascular repair (EVAR) for abdominal aortic aneurysm (AAA); however, only few dedicated experiences have been reported in the literature. The aim of the study was to evaluate the incidence, presentation and treatment of late ELIB and to identify possible anatomical and technical predictors. METHODS: All patients undergoing elective EVAR between 2008 and 2013 were collected prospectively. Follow up was by post-operative computed tomography angiography (CTA) performed within 30 days and CTA and/or duplex ultrasound (DUS) at six or 12 months and yearly thereafter. Patients with late ELIB, defined as distal type I endoleak detected more than six months after the primary intervention without endoleak on the intra-operative completion angiogram and on the post-operative CTA, were retrospectively selected (G1) and compared with a control group with no ELIB (G2) homogeneous for clinical conditions, endograft implanted, and timing of follow up. The minimum follow up required for inclusion in the study was 24 months. Pre-operative morphological aorto-iliac features and EVAR implant details were evaluated, and measurements performed after centre lumen line reconstructions using dedicated software. The differences between G1 and G2 were analysed using the chi-square test, the Student t test, and logistic regression. RESULTS: Six hundred and sixteen patients were submitted to EVAR. ELIB was detected in 14 cases (2.3%) (G1) at a median follow up of 32.8 (IQR 48) months. In three of the 14 cases ELIB was symptomatic (AAA rupture, 2; pain, 1); in the remaining 11 cases it was asymptomatic and found incidentally at routine follow up. Treatment was by open repair in one case and by endovascular iliac leg extension in 13 cases. Hypogastric exclusion was necessary in two of 14 cases. Thirty patients were included in G2, with a median follow up of 41.2 (25) months. Common iliac artery length <4 cm (OR 5.3, 95% CI 1.1-29.5, p = .05), diameter > 15 mm (OR 3.5, 95% CI 1.2-10.9, p = .03), and severe thrombotic apposition (>50% of circumference) (OR 5, 95% CI 1.2-19.2, p = .02), at the iliac sealing zone were significant predictors of ELIB, on univariable analysis; oversizing of the iliac leg diameter < 10% and distal sealing > 1 cm above the hypogastric origin were independently associated with ELIB (OR 5.4, 95% CI 1.3-21.5, p = .01 and OR 6.6, 95% CI 1.1-39.3, p = .03, respectively), on multivariable analysis. CONCLUSION: The present data underline that ELIB is a non-negligible occurrence during long term EVAR follow up and requires further interventions, most often by endovascular solutions. According to the ELIB risk factors identified in this study, an iliac leg diameter oversize >10% and extensive common iliac artery coverage (<1 cm above the hypogastric origin) would be suggested to prevent this complication.

First/Preliminary Experience of Gore Viabahn Balloon-Expandable Endoprosthesis as Bridging Stent in Fenestrated and Branched Endovascular Aortic Repair.

BACKGROUND: The aim of this study is to evaluate the preliminary outcomes of the Gore® Viabahn® balloon-expandable endoprosthesis (VBX) as bridging stent for fenestrated/branched aortic endograft. METHODS: Between April and June 2018, patients undergoing fenestrated and branched-endovascular aortic repair were prospectively collected. Anatomical, procedural, and postoperative data of patients treated with VBX as bridging stents to connect fenestrations/branches to target visceral vessels (TVVs) were analyzed. Technical success and any TVV-related adverse event were assessed before discharge, at 30 days, and after 6 months of follow-up. RESULTS: Fifteen patients undergoing fenestrated and branched-endovascular aortic repair for juxta/pararenal aneurysms (11), proximal type I endoleak after endovascular aortic repair (1), and thoracoabdominal aneurysms (3) were included in the study. Overall, 60 TVVs-celiac trunk (n = 14), superior mesenteric artery (n = 13), renal arteries (n = 30), hypogastric artery (n = 3)-were accommodated by fenestrations (n = 51), branches (n = 7), and scallops (n = 2). The bridging stent graft was a VBX in 40 (67%) TVVs. A renal artery dissection was successfully managed by a self-expandable bare metal stent. Overall, relining of a bridging stent graft was required in 2 TVVs revascularized by fenestrations (superior mesenteric artery: n = 1, renal artery: n = 1). One intraoperative type III endoleak from renal fenestration was detected and successfully sealed by an adjunctive flaring maneuver. Technical success was achieved in all cases. At 5-day, 1 VBX (1/40: 2.5%) lost its sealing in a renal artery revascularized by a branch (type II thoracoabdominal aortic aneurysm) and required reintervention and relining with a self-expandable stent graft. No TVV occlusion or reintervention occurred <30 days or after 6 months of follow-up. CONCLUSIONS: According to these preliminary results, the Gore Viabahn VBX balloon-expandable endoprosthesis can be safely used as bridging stent graft for fenestrated or branched endografts. A longer follow-up with a larger case load is necessary in order to validate this preliminary experience.

Renal Artery Orientation Influences the Renal Outcome in Endovascular Thoraco-abdominal Aortic Aneurysm Repair.

OBJECTIVE: To evaluate the impact of renal artery (RA) anatomy on the renal outcome of fenestrated-branched endografts (FB-EVAR) for thoraco-abdominal aortic aneurysms (TAAA). METHODS: Between 2010 and 2016, all patients undergoing FB-EVAR for TAAA were prospectively collected. Anatomical, procedural, and post-operative data were retrospectively analysed. RA anatomy was assessed on volume rendering, multi planar and centre line reconstructions by dedicated software (3Mensio). RA diameter, length, ostial stenosis/calcification, orientation and aortic angles of the para-visceral aorta were evaluated. RA orientation was classified in four types: A (horizontal), B (upward), C (downward), D (downward + upward). RA revascularisation by fenestrations or branches was considered. Inability to cannulate and stent RA (RA loss), early RA occlusion (within three months), and composite RA events (one among RA loss, intra-operative RA lesion, RA related re-interventions, RA occlusion) were assessed. RESULTS: Seventy-three patients (male 77%; age 73 ± 6 years) with 39 (53%) type I, II, III and 34 (47%) type IV TAAA, underwent FB-EVAR, for a total of 128 RAs. The mean RA diameter and length were 6 ± 1 mm and 43 ± 12 mm, respectively. Type A, B, C, and D orientations were 51 (40%), 18 (14%), 48 (36%), and 11 (10%) RAs, respectively. Angulation of para-visceral aorta >45° was present in 14 cases (19%). Ostial stenosis and calcifications were detected in 20 (16%) and 16 (13%) RAs, respectively. Branches and fenestrations were used in 43 (34%) and 85 (66%) RAs, respectively. There were four (3%) intra-operative RA lesions (2 ruptures, 2 dissections). Ten (8%) RAs were lost intra-operatively because of the inability to cannulating and stenting. On univariable analysis, type B RA orientation (p = .001; OR 13.2; 95% CI 3.2-53.6), para-visceral aortic angle > 45° (p = .02; OR 4.9; 95% CI 1.3-18.5) and branches (p = .003; OR 9.0; 95% CI 1.9-46.9) were risk factors for intra-operative RA loss; type C RA orientation was a protective factor (p = .02; OR 0.1; 95% CI 0.01-0.9). On multivariable analysis, type B RA orientation (p = .03; OR 5.9; 95% CI 1.1-31.1) and branches (p = .03; OR 7.3; 95% CI 1.1-47.9) were independent risk factors for intra-operative RA loss. Fourteen patients suffered post-operative renal function worsening (> 30% of the baseline). The mean follow up was 19 ± 12 months. Four (3%) early RA occlusions occurred in three patients (2 single kidney patients required permanent haemodialysis). Type D RA orientation (p = .00; RR 17.8; 8.6-37.0) and branches (p = .004; RR 3.2; 2.4-4.1) were risk factors for early RA occlusion on univariable analysis. Five patients (7%) required early RA related re-interventions (recanalisation + relining 3; stent graft extension 1; parenchymal embolisation 1). No late RA occlusion or re-interventions were reported during follow up. Composite RA events occurred in 17 (13%) cases. Type B (p = .05; OR 3.9; 95% CI 1.1-15.7) or D (p = .006; OR 10.9; 95% CI 2.3-50.8) RA orientations and branches (p = .006; OR 5.7; 95% CI 1.6-20.3) were independent predictors of composite RA events on multivariable analysis. CONCLUSION: Renal artery orientation significantly affects the early RA outcome of FB-EVAR for TAAA. Intra-operative RA loss is predicted by type B RA orientation and branches, while early RA occlusion is predicted by type D orientation and branches. The present data suggest that in TAAA, fenestrations should be the first choice for renal revascularisation in type B and D RA orientations.

Outcomes of Duplex-Guided Paramalleolar and Inframalleolar Bypass in Patients with Critical Limb Ischemia.

BACKGROUND: The aim of the study was to evaluate the outcomes of duplex ultrasonography (DUS)-guided autologous vein bypass to paramalleolar (distal third of tibial arteries and peroneal artery) and inframalleolar arteries (dorsalis pedis, common plantar, medial, and lateral plantar arteries) in patients with critical limb ischemia (CLI) and extensive tibial artery disease Trans-Atlantic Inter-Society Consensus D. METHODS: Between January 2007 and October 2016, all paramalleolar or inframalleolar bypasses performed in patients with CLI, planned only on the basis of DUS, were collected and analyzed retrospectively. DUS evaluation included arterial disease extension, inflow and outflow arteries' diameter, outflow vessels resistance, and autologous veins quality. Patient's demographics and clinical characteristics were assessed. Tissue loss was graded according to Texas University Wound Classification (TWC). Follow-up included periodic clinical and DUS examinations. Primary end points were technical success (TS) (patent bypass with distal anastomosis performed on the Duplex-selected runoff artery, without stenosis >30% and in line flow with the inframalleolar arteries at completion angiography and without hemodynamic bypass stenosis at postoperative DUS) and bypass patency (primary [PP], assisted [AP], and secondary [SP]). Secondary end points were perioperative and follow-up patient survival (PS), limb salvage (LS), and amputation-free survival (AFS). Descriptive statistics and Kaplan-Meier analysis were performed. Univariate and Multivariate Cox analyses were used to define risk factors. RESULTS: Seventy-four bypasses in 73 patients with CLI (Rutherford 5-6 93.2%, TWC stage III in 63.5% and grade D in 48.6%) were performed in the study period (January 2007-October 2016). diabetes mellitus, coronary artery disease, and kidney disease were present in 67.6%, 60.8%, and 37.8% patients, respectively. Distal anastomosis was performed at the paramalleolar and inframalleolar arteries in 47.3% and 52.7%, respectively. Only autologous veins were used as conduit. TS was 98.6%. At 1-month, PP, AP, SP, PS, LS, and AFS were 87.8%, 91.9%, 93.2%, 95.9%, 94.6%, and 90.5%, respectively. The mean follow-up was 33.7 months; at 1-year, PP, AP, SP, PS, LS, and AFS were 54.4%, 71.4%, 75.1%, 89.9%, 84.3%, and 79.1%, respectively, and at 3-year, 42.3%, 63%, 66%, 67.5%, 80.6%, and 61%, respectively. At univariate and multivariate analyses, arterial hypertension was protective for PP (P = 0.035) while insulin-dependent diabetes was a negative predictor (P = 0.01); insulin-dependent diabetes was a negative predictor of LS (P = 0.002); TWC grade D was a negative predictor of AP (P = 0.047) and SP (P = 0.013). Age (P < 0.001) and major amputation (P = 0.014) resulted as negative predictors of PS. CONCLUSIONS: Bypass of the Duplex-selected paramalleolar and inframalleolar arteries in CLI has high TS and high rate of perioperative and late LS. Duplex evaluation and planning in CLI patients with extensive tibial arteries disease is associated with efficacy of surgical revascularization and high LS rates.

Impact of angiosome- and nonangiosome-targeted peroneal bypass on limb salvage and healing in patients with chronic limb-threatening ischemia.

BACKGROUND: Direct (DIR) or indirect (IND) revascularization of pedal angiosomes in patients with chronic limb-threatening ischemia (CLTI) has an unclear impact on limb salvage and healing. The aim of this study was to evaluate the outcomes of DIR and IND revascularization in patients with a peroneal bypass and tissue loss. METHODS: We conducted a retrospective study of a prospectively maintained database in two European university centers from 2004 to 2015. We extracted from this database all patients with CLTI and tissue loss who had received a bypass to the peroneal artery. All patients underwent angiography before bypass. Revascularization was considered DIR if the wound was in a peroneal angiosome. Wounds, ischemia, and infection were categorized according to the Wound, Ischemia, and foot Infection (WIfI) classification. Limb salvage and amputation-free survival were calculated using the Kaplan-Meier method. Cox regression was used to compare the role of patient characteristics, including diabetes, peroneal runoff, pedal arch angiosome, WIfI grade, chronic kidney disease, and diabetes, in amputation-free-survival. RESULTS: From January 2004 through October 2015, there were 120 peroneal bypasses performed in 120 patients with CLTI and foot tissue loss. Only 55 wounds (46%) could be ascribed to a peroneal angiosome. At 3 years, amputation-free survival in patients with DIR revascularization was 54.9% ± 7.3% compared with 56.5% ± 6.3% in patients with IND revascularization (P = .44), with no significant difference in wound healing. Amputation-free survival at 3 years in patients with two patent peroneal branches was 74.8% ± 6.9% compared with 45.0% ± 6.0% in patients with one patent peroneal branch (P = .003). Amputation-free survival at 3 years in patients with a patent pedal arch (Rutherford 0-1) was 73.0% ± 7.0% vs 45.7% ± 6.0% in patients with incomplete pedal arch (Rutherford 2-3; P = .0002). Amputation-free survival at 3 years in patients with grade 1 or grade 2 WIfI was 87.4% ± 8.3% compared with 48.4% ± 5.3% in patients with grade 3 or grade 4 WIfI (P = .001). Amputation-free survival at 3 years in patients with diabetes was 43.7% ± 6.2% compared with 73.1% ± 6.7% in patients without diabetes (P = .002). Wound healing at 6 months was not significantly improved by its location within or outside a peroneal angiosome. Cox regression analysis demonstrated that diabetes, patency of both peroneal branches, patency of pedal arch, and WIfI stage but not DIR angiosome revascularization were significant predictors of amputation-free survival. CONCLUSIONS: Our results suggest that in patients with CLTI and tissue loss receiving a peroneal bypass, patency of both peroneal branches and pedal arch was associated with a better healing rate and a better amputation-free survival rate irrespective of wound angiosome location.

Aorto-iliac and infrainguinal artery occlusive disease: different revascularization options according to the critical limb threatening ischemia category.

BACKGROUND: Critical limb threatening-ischemia (CLTI) can be due to an extensive involvement of both the aorto-iliac (AI) and the infra-inguinal (II) districts and the efficacy of and extensive AI+II vs. only AI revascularization is still matter of debate. The aim of the present study was to evaluate the outcome in CLTI patients with concomitant AI and II peripheral artery disease (PAD) after revascularization limited to the AI or extended also to the II segment. METHODS: Patients with CLTI and concomitant AI (TransAtlantic InterSociety Consensus: C-D) and II PAD (Global-Anatomic-Staging-System: II-III) from 2016 to 2021 were retrospectively evaluated. Patients were compared according to type of revascularization: limited to AI vs. AI+II. Common femoral and profunda artery endarterectomy (C/P-TEA) was considered in both groups. Perioperative mortality, limb salvage, foot healing (within 6 months after surgery), necessity of adjunctive revascularization and survival were analyzed and the follow-up performed with clinical and duplex assessment every six months. The primary endpoint was to evaluate the composite event of limb salvage, wound healing and necessity of adjunctive revascularization during follow-up in AI vs. AI+II groups, through Kaplan Meier and Cox regression analysis. RESULTS: Over a total of 1105 peripheral revascularizations for CLTI, 96 (8.7%) patients met the inclusion criteria for the study. AI revascularization was performed in 38 (40%) and AI+II in 58 (60%). AI and AI+II groups were similar for preoperative risk factors and extension of PAD with the exception of American Society of Anesthesiology (ASA) Classification (ASA IV: 50% vs. 25%, P=0.02, respectively). The AI group was treated with angioplasty/stenting in all cases and with C/P-TEA in 20 (52%) cases. In the AI+II group, the AI district was treated by angioplasty/stenting in 55 (95%) and by aorto-bifemoral bypass in 3 (5%) and C/P-TEA in 20 (34%). The II revascularization was performed by femoro-popliteal/tibial bypass in 27 (47%); and endovascular revascularization in 31 (53%) patients. Minor amputation rate was similar between AI and AI+II revascularization (39% vs. 48%, P=1.0); length of stay, blood transfusion units, were significantly higher in AI+II group: 7±4 days vs. 12±5 days, P=0.04 and 2±2 vs. 4±2, P=0.02. The 30-day mortality was 7% with no differences according to the type of treatment. At a mean follow-up of 28±10 months, the overall limb salvage was 87±4% with similar results in AI vs. AI+II revascularization (95±5% vs. 86±6%; P=0.56). AI had a higher necessity of adjunctive revascularization and lower wound healing compared to AI+II (18±9% vs. 0%, P=0.02; 72% vs. 100%, P=0.001, respectively). AI+II was associated with a better primary endpoint compared to AI (87±5% vs. 53±9%, P=0.01), and it was confirmed in Rutherford 5 and 6 patients (100% vs. 54±14%, P=0.01; 78±9 vs. 50±13%, P=0.04), and no differences in Rutherford 4 (100% vs. 100%). Cox regression analysis confirmed AI+II as an independent protector for the primary outcome (hazard ratio: 0.23, 95% confidence interval 0.08-0.71). CONCLUSIONS: CLTI with extensive PAD disease can be treated with limited AI revascularization in Rutherford 4 patients however in case of category 5 or 6 an extensive revascularization (AI+II) should be considered.

Outcomes of radiocephalic arteriovenous fistula in octogenarians.

BACKGROUND: Current guidelines recommend radiocephalic arteriovenous fistula (RCAVF) as a first choice access for hemodialysis, without specific indication for octogenarians .This study was undertaken to assess the efficacy of RCAVF in octogenarians compared with younger patients. MATERIAL AND METHODS: All patients treated by RCAVF from January 2013 to December 2017 were included in a prospective database for a retrospective analysis. Patient demographics, comorbidities, and dialytic treatment data were collected prospectively and compared in patients <80 year-old and ⩾80 years-old. Clinical surveillance was performed during each dialysis session. The main endpoints were primary (PP) and assisted patency (AP). RESULTS: Within the study period, a total of 294 RCAVF were analyzed: 245 (83.3%) RCAVF were performed in <80 year-old and 49 (16.7%) ⩾80 years old. The overall PP and AP at 2-year was 69% ± 2% and 73% ± 3%, respectively. Patients ⩾ 80 years-old had a significantly reduced 2-year PP, AP of RCAVF compared with the younger patients: 50% ± 8% and 62% ± 7% versus 73% ± 3% and 75% ± 3%, p = 0.01 and p = 0.03, respectively.The analysis for possible risk factors for reduction of PP in patients ⩾80 years identified in the central venous catheter(CVC) a predictor of earlier RCAVF failure: HR 3.03(95% CI 1.29-7.13), p = 0.01.Kaplan-Meier curve confirms the reduction of PP in ⩾80 years old patients at 2-year follow-up with previous CVC compared patients without history of CVC: 59% ± 10% versus 24% ± 11%, p = 0.01. A comparison between the two groups was made in order to evaluate the impact of previous history of CVC .In absence of a history of CVC use older patients had a similar 2-year PP compared with younger patients: 59% ± 10% versus 72% ± 4%, p = 0.46. Otherwise, the history of a previous CVC reduced significantly the 2-year PP in ⩾80 years old patients compared the younger: 24% ± 12% versus 75% ± 5%, p = 0.0001. CONCLUSIONS: Despite lower overall primary and primary assisted patency, RCAVF are associated with satisfactory results also in octogenarians if performed in absence of history of CVC. Under these circumstances RCAVF can be considered a first choice treatment.

MicroRNA profiles of human peripheral arteries and abdominal aorta in normal conditions: MicroRNAs-27a-5p, -139-5p and -155-5p emerge and in atheroma too.

Atherosclerosis may starts early in life and each artery has peculiar characteristics likely affecting atherogenesis. The primary objective of the work was to underpin the microRNA (miR)-profiling differences in human normal femoral, abdominal aortic, and carotid arteries. The secondary aim was to investigate if those identified miRs, differently expressed in normal conditions, may also have a role in atherosclerotic arteries at adult ages. MiR-profiles were performed on normal tissues, revealing that aorta and carotid arteries are more similar than femoral arteries. MiRs emerging from profiling comparisons, i.e., miR-155-5p, -27a-5p, and -139-5p, were subjected to validation by RT-qPCR in normal arteries and also in pathological/atheroma counterparts, considering all the available 20 artery specimens. The three miRs were confirmed to be differentially expressed in normal femoral vs aorta/carotid arteries. Differential expression of those miRs was also observed in atherosclerotic arteries, together with some miR-target proteins, such as vimentin, CD44, E-cadherin and an additional marker SLUG. The different expression of miRs and targets/markers suggests that aorta/carotid and femoral arteries differently activate molecular drivers of pathological condition, thus conditioning the morphology of atheroma in adult life and likely suggesting the future use of artery-specific treatment to counteract atherosclerosis.